15. The composition of claim 14, wherein said composition comprises about
1500 IU to about 4500 IU carotenoids, about 50 IU to about 150 IU vitamin
E, about 500 IU to about 1500 IU vitamin D3, about 150 mg to about 450 mg
vitamin C, 0.5 mg to about 1.5 mg folic acid, about 12.5 mg to about 37.5
mg pyridoxine, about 25 μg to about 75 μg cobalamin, about 10 mg to
about 30 mg thiamin, about 2.5 mg to about 7.5 mg riboflavin, about 12.5
mg to about 37.5 mg niacin, about 7.5 mg to about 22.5 mg pantothenic
acid, about 50 μg to about 150 μg biotin, about 25 mg to about 75
mg magnesium, about 0.75 mg to about 2.25 mg manganese, about 12.5 mg to
about 37.5 mg zinc, about 50 μg to about 150 μg selenium, about 25
μg to about 75 μg chromium, about 0.75 mg to about 2.25 mg copper,
about 7.5 mg to about 22.5 mg alpha lipoic acid, and about 2.5 mg to
about 7.5 mg lutein.

30. The method of claim 19, wherein said vitamin D is present in the range
of about 500 IU to about 1500 IU.

31. The method of claim 19, wherein said vitamin D is present in the
amount of about 1000 IU.

32. A method comprising administering to a patient the composition of
claim 14.

33. The method of claim 32, wherein said composition comprises about 1500
IU to about 4500 IU carotenoids, about 50 IU to about 150 IU vitamin E,
about 500 IU to about 1500 IU vitamin D3, about 150 mg to about 450 mg
vitamin C, 0.5 mg to about 1.5 mg folic acid, about 12.5 mg to about 37.5
mg pyridoxine, about 25 μg to about 75 μg cobalamin, about 10 mg to
about 30 mg thiamin, about 2.5 mg to about 7.5 mg riboflavin, about 12.5
mg to about 37.5 mg niacin, about 7.5 mg to about 22.5 mg pantothenic
acid, about 50 μg to about 150 μg biotin, about 25 mg to about 75
mg magnesium, about 0.75 mg to about 2.25 mg manganese, about 12.5 mg to
about 37.5 mg zinc, about 50 μg to about 150 μg selenium, about 25
μg to about 75 μg chromium, about 0.75 mg to about 2.25 mg copper,
about 7.5 mg to about 22.5 mg alpha lipoic acid, and about 2.5 mg to
about 7.5 mg lutein.

[0002]Nutrition plays a critical role in maintaining good health. Proper
nutrition prevents dietary deficiencies, and also protects against the
development of disease. Proper nutrition plays an increasingly important
role as the body faces physiological stress. For example, as the body
ages it suffers significant physiological stresses. Specifically, as the
body metabolism shifts to accumulating larger fat stores and decreasing
lean body mass, this increase in body weight may lead to obesity and
associated conditions such as diabetes, cardiovascular disease,
hypertension, osteoarthritis, and cancer. Other conditions, such as
anorexia, malnutrition, gastrointestinal disorders, chronic alcoholism,
chronic infections, acute infections, congestive heart failure,
hyperthyroidism, poorly controlled diabetes, cheilosis, gingivitis,
stomatitis and dietary restrictions, often result in physiological
stresses that may be exacerbated by poor nutrition. In particular, these
disease states may result in increased oxidative stress or elevated
homocysteine levels that further compromise health. Thus, nutritional
supplementation serves a vital role in protecting against poor nutrition
and disease.

[0003]Nutritional supplementation, however, is an evolving science. As
research is determining the beneficial effects of nutritional supplements
are findings that the recommended daily allowance of some nutrients and
vitamins may still not be sufficient. For example, recent research
suggests that vitamin D has more positive physiological effects than
previous thought. It has recently been determined that vitamin D has
previously unknown roles in the enhancement of vascular function, defense
against cancer, immuno-competence, blood pressure regulation and
possessing the ability to enhance cellular insulin sensitivity in the
human body.

[0005]Current nutritional supplements, however, do not include high enough
dosage amounts to obtain such a high serum level of 25-hydroxyvitamin D
in patients. A nutritional supplement that includes a higher dosage
amount of vitamin D is therefore currently needed.

[0006]Thus, the invention herein provides for compositions and methods,
designed to optimize health and wellness, minimize oxidative stress, and
provide a beneficial increased supplementation of vitamin D.

SUMMARY OF THE INVENTION

[0007]The present invention provides nutritional compositions and methods
of using these compositions for both prophylactic and therapeutic
nutritional supplementation, specifically in physiologically stressful
conditions. The present invention also relates to novel compositions of
vitamins and minerals that can be used to supplement nutritional
deficiencies of vitamin D observed in patients and illnesses and health
issues such as anorexia, malnutrition, gastrointestinal disorders,
chronic alcoholism, chronic infections, acute infections, congestive
heart failure, hyperthyroidism, poorly controlled diabetes, cheilosis,
gingivitis, stomatitis, and/or dietary restrictions. In addition, the
compositions may be used to treat the nutritional deficiencies of
patients suffering from a disease state that results in increased
oxidative stress or elevated homocysteine levels.

[0008]The compositions of the present invention include various vitamins,
minerals, antioxidants and nutrients that improve the nutritional state
of a patient; these compositions preferably may be used therapeutically
or prophylacticly.

[0010]In another embodiment of the present invention, the compositions may
comprise carotenoids selected from the group consisting of
alpha-carotene, beta-carotene, cryptoxanthin, lutein, and zeaxanthin. In
another embodiment of the present invention, the carotenoids may include
lutein and zeaxanthin.

[0011]In another embodiment of the present invention, the compositions may
include vitamin D, wherein vitamin D comprises vitamin D3. In another
embodiment of the present invention, the compositions may include vitamin
B12, wherein vitamin B12 comprises cobalamin. In another embodiment of
the present invention, the compositions may include vitamin B6, wherein
vitamin B6 comprises pyridoxine. In another embodiment of the present
invention, the compositions may include vitamin B1, wherein vitamin B1
comprises thiamin. In another embodiment of the present invention, the
compositions may include vitamin B2, wherein vitamin B2 comprises
riboflavin. In another embodiment of the present invention, the
compositions may include vitamin B3, wherein vitamin B3 comprises niacin.
In another embodiment of the present invention, the compositions may
include vitamin B5, wherein vitamin B5 comprises pantothenic acid.

[0012]In another embodiment of the present invention, the compositions may
comprise vitamin D present in the range of about 500 IU to about 1500 IU.
In another embodiment of the present invention, the compositions may
comprise vitamin D present in the amount of about 1000 IU.

[0013]In another embodiment of the present invention, the compositions may
comprise carotenoids, vitamin E, more than 480 IU vitamin D3, vitamin C,
folic acid, pyridoxine, cobalamin, thiamin, riboflavin, niacin,
pantothenic acid, biotin, magnesium, manganese, zinc, selenium, chromium,
copper, alpha lipoic acid, and lutein. In another embodiment of the
present invention, the compositions may comprise about 1500 IU to about
4500 IU carotenoids, about 50 IU to about 150 IU vitamin E, about 500 IU
to about 1500 IU vitamin D3, about 150 mg to about 450 mg vitamin C,
about 0.5 mg to about 1.5 mg folic acid, about 12.5 mg to about 37.5 mg
pyridoxine, about 25 μg to about 75 μg cobalamin, about 10 mg to
about 30 mg thiamin, about 2.5 mg to about 7.5 mg riboflavin, about 12.5
mg to about 37.5 mg niacin, about 7.5 mg to about 22.5 mg pantothenic
acid, about 50 μg to about 150 μg biotin, about 25 mg to about 75
mg magnesium, about 0.75 mg to about 2.25 mg manganese, about 12.5 mg to
about 37.5 mg zinc, about 50 μg to about 150 μg selenium, about 25
μg to about 75 μg chromium, about 0.75 mg to about 2.25 mg copper,
about 7.5 mg to about 22.5 mg alpha lipoic acid, and about 2.5 mg to
about 7.5 mg lutein. In another embodiment of the present invention, the
compositions may comprise about 3000 IU carotenoids, about 100 IU vitamin
E, about 1000 IU vitamin D3, about 300 mg vitamin C, about 1.0 mg folic
acid, about 25 mg pyridoxine, about 50 μg cobalamin, about 20 mg
thiamin, about 5 mg riboflavin, about 25 mg niacin, 15 mg pantothenic
acid, 100 μg biotin, about 50 mg magnesium, about 1.5 mg manganese,
about 25 mg zinc, about 100 μg selenium, about 50 μg chromium,
about 1.5 mg copper, about 15 mg alpha lipoic acid, and about 5 mg
lutein. In another embodiment of the present invention, the compositions
may further comprise one or more pharnaceutical carriers and is
administrable to a patient. In another embodiment of the present
invention, the compositions may be administrable to the patient orally.

[0014]The present invention also includes methods of administering the
compositions of the present invention to a patient for both prophylactic
and therapeutic nutritional supplementation. In a specific embodiment of
the present invention, the methods may include administering to a patient
a composition comprising carotenoids, vitamin E, vitamin D, vitamin C,
folic acid, vitamin B6, vitamin B12, vitamin B1, vitamin B2, vitamin B3,
vitamin B5, biotin, magnesium, manganese, zinc, selenium, chromium,
copper, alpha lipoic acid, and lutein. In a specific embodiment, the
compositions of the present invention may include more than 480 IU
vitamin D. In another embodiment of the present invention, the methods
may utilize compositions comprising carotenoids, vitamin E, more than 480
IU vitamin D, vitamin C, folic acid, vitamin B6, vitamin B12, vitamin B1,
vitamin B2, vitamin B3, vitamin B5, biotin, magnesium, manganese, zinc,
selenium, chromium, copper, alpha lipoic acid, and lutein. In another
embodiment of the present invention, the compositions may further
comprise one or more pharmaceutically acceptable carriers.

[0015]In another embodiment of the present invention, the methods may
utilize compositions comprising carotenoids selected from the group
consisting of alpha-carotene, beta-carotene, cryptoxanthin, lutein, and
zeaxanthin. In another embodiment of the present invention, the
carotenoids may include lutein and zeaxanthin.

[0016]In another embodiment of the present invention, the methods may
utilize vitamin D, wherein vitamin D comprises vitamin D3. In another
embodiment of the present invention, the methods may utilize vitamin B12,
wherein vitamin B12 comprises cobalamin. In another embodiment of the
present invention, the methods may utilize vitamin B6, wherein vitamin B6
comprises pyridoxine. In another embodiment of the present invention, the
methods may utilize vitamin B1, wherein vitamin B1 comprises thiamin. In
another embodiment of the present invention, the methods may utilize
vitamin B2, wherein vitamin B2 comprises riboflavin. In another
embodiment of the present invention, the methods may utilize vitamin B3,
wherein vitamin B3 comprises niacin. In another embodiment of the present
invention, the methods may utilize vitamin B5, wherein vitamin B5
comprises pantothenic acid.

[0017]In another embodiment of the present invention, the methods may
utilize compositions comprising vitamin D present in the range of about
500 IU to about 1500 IU. In another embodiment of the present invention,
the methods may utilize compositions comprising vitamin D present in the
amount of about 1000 IU.

[0018]In another embodiment of the present invention, the methods may
utilize compositions comprising carotenoids, vitamin E, more than 480 IU
vitamin D3, vitamin C, folic acid, pyridoxine, cobalamin, thiamin,
riboflavin, niacin, pantothenic acid, biotin, magnesium, manganese, zinc,
selenium, chromium, copper, alpha lipoic acid, and lutein. In another
embodiment of the present invention, the methods may utilize compositions
comprising about 1500 IU to about 4500 IU carotenoids, about 50 IU to
about 150 IU vitamin E, about 500 IU to about 1500 IU vitamin D3, about
150 mg to about 450 mg vitamin C, about 0.5 mg to about 1.5 mg folic
acid, about 12.5 mg to about 37.5 mg pyridoxine, about 25 μg to about
75 μg cobalamin, about 10 mg to about 30 mg thiamin, about 2.5 mg to
about 7.5 mg riboflavin, about 12.5 mg to about 37.5 mg niacin, about 7.5
mg to about 22.5 mg pantothenic acid, about 50 μg to about 150 μg
biotin, about 25 mg to about 75 mg magnesium, about 0.75 mg to about 2.25
mg manganese, about 12.5 mg to about 37.5 mg zinc, about 50 μg to
about 150 μg selenium, about 25 μg to about 75 μg chromium,
about 0.75 mg to about 2.25 mg copper, about 7.5 mg to about 22.5 mg
alpha lipoic acid, and about 2.5 mg to about 7.5 mg lutein. In another
embodiment of the present invention, the compositions may comprise about
3000 IU carotenoids, about 100 IU vitamin E, about 1000 IU vitamin D3,
about 300 mg vitamin C, about 1.0 mg folic acid, about 25 mg pyridoxine,
about 50 μg cobalamin, about 20 mg thiamin, about 5 mg riboflavin,
about 25 mg niacin, 15 mg pantothenic acid, 100 μg biotin, about 50 mg
magnesium, about 1.5 mg manganese, about 25 mg zinc, about 100 μg
selenium, about 50 pig chromium, about 1.5 mg copper, about 15 mg alpha
lipoic acid, and about 5 mg lutein. In another embodiment of the present
invention, the methods may utilize compositions comprising one or more
pharmaceutical carriers and are administrable to a patient. In another
embodiment of the present invention, the methods may utilize compositions
wherein the composition may be administered to the patient orally.

DETAILED DESCRIPTION

[0019]It is understood that the present invention is not limited to the
particular methodologies, protocols, fillers, excipients, etc., described
herein, as these may vary. It is also to be understood that the
terminology used herein is used for the purpose of describing particular
embodiments only, and is not intended to limit the scope of the present
invention. It must be noted that as used herein and in the appended
claims, the singular forms "a," "an," and "the" include the plural
reference unless the context clearly dictates otherwise. Thus, for
example, a reference to "a vitamin" is a reference to one or more
vitamins and includes equivalents thereof known to those skilled in the
art and so forth.

[0020]Unless defined otherwise, all technical and scientific terms used
herein have the same meanings as commonly understood by one of ordinary
skill in the art to which this invention belongs. Specific methods,
devices, and materials are described, although any methods and materials
similar or equivalent to those described herein can be used in the
practice or testing of the present invention.

[0021]The term "subject," as used herein, comprises any and all organisms
and includes the term "patient." "Subject" may refer to a human or any
other animal.

[0022]The phrase "pharmaceutically acceptable," as used herein, refers to
those compounds, materials, compositions and/or dosage forms which are,
within the scope of sound medical judgment, suitable for use in contact
with the tissues of human beings and animals without excessive toxicity,
irritation, allergic response, or other problem or complication,
commensurate with a reasonable benefit/risk ratio. Thus, the phrase
"pharmaceutically acceptable carriers," as used herein, refers to such
suitable compounds and materials defined above that may be added to the
dosage form to assist in satisfactory processing of the dosage form or
provide desirable physical characteristics to the dosage form. For
example, "pharmaceutically acceptable carriers" may include, but is not
limited to, binders, diluents, lubricants, glidants, colorants,
emulsifiers, disintegrants, starches, water, oils, alcohols,
preservatives, and sugars.

[0023]The phrase "swallowable form" refers to any compositions that do not
readily dissolve when placed in the mouth and may be swallowed whole
without any chewing or discomfort. Such compositions, in one embodiment,
may have a shape containing no sharp edges and a smooth, uniform and
substantially bubble free outer coating.

[0024]The term "dosage form," as used herein, is the form in which the
dose is to be administered to the subject or patient. The drug or
supplement is generally administered as part of a formulation that
includes nonmedical agents. The dosage form has unique physical and
pharmaceutical characteristics. Dosage forms may be solid, liquid or
gaseous. Solid forms include, but are not limited to pills, capsules,
tablets, gel caplets, softgels, lozenges, wafers etc.

[0025]The term "substantially free of added" as used herein, means free
from therapeutically effective amounts of compounds when administered in
suggested doses, but may include trace amounts of compounds in
non-therapeutically effective amounts.

[0026]As used herein, the terms "inactive," "inert," "excipient," and/or
"formulatory" refer to any compound that is an inactive ingredient of a
described composition. The definition of "inactive ingredient" as used
herein follows that of the U.S. Food and Drug Administration, as defined
in 21 C.F.R. 201.3(b)(8), which is any component of a drug product other
than the active ingredient.

[0027]By "active ingredient," then, is meant any compound intended to
furnish pharmacological activity or other direct effect in the diagnosis,
cure, mitigation, treatment and/or prevention of a condition. See 21
C.F.R. 210.3(b)(7). Further, "active ingredients" include those compounds
of the composition that may undergo chemical change during the
manufacture of the composition and be present in the final composition in
a modified form intended to furnish an activity or effect. Id.

[0028]The term "administrable" defines a composition that is able to be
given to a patient. Likewise, "administering" refers to the act of giving
a composition to a patient or otherwise making such composition available
to a patient or the patient taking a composition.

[0029]As used herein, the term "about," when located before a dosage
amount or dosage range of a specific ingredient, refers to an amount or
range closely above and/or closely below the stated amount or range that
does not manifestly alter the therapeutic effect of the specific
ingredient from the stated amount or range.

[0030]As used herein, the term "comprising" means that the present
invention includes the listed ingredients thereafter, but does not
exclude additional or unrecited ingredients.

[0031]As used herein, the term "consisting essentially of" means that the
present invention includes the listed ingredients thereafter, and
excludes only the ingredients that materially affect the basic and novel
characteristic of the composition.

[0032]As used herein, the term "consisting of" means that the present
invention includes only the ingredients listed thereafter.

[0033]Proper nutrition is essential for maintaining health and preventing
diseases. The compositions and methods of the present invention provide
the means to optimize good health by utilizing vitamin, mineral, and
antioxidant nutritional supplementation. Specifically, the compositions
of the present invention contain a variety of antioxidants, which may
minimize free radical concentrations and minimize the deleterious effects
of oxidative stress, and vitamins and minerals that support normal levels
of homocysteine. More specifically, the compositions and methods of the
present invention provide a beneficial increased supplementation of
vitamin D due to the recent awareness of the increased role and
importance that vitamin D has in the human body.

[0034]The compositions of the present invention may also comprise
antioxidant factors that may protect against oxidative stress. Oxidative
stress occurs as the body's natural use of oxygen creates unstable
molecules known as free radicals, which steal stable electron partners
from other molecules, launching more free radicals and increased
molecular and cellular instability. This coxidative stress' is implicated
in over 200 diseases, including cardiovascular disease and cancer, which
are attributed to free radical oxidation. Rock et al., 96 J. AM. DIETARY
ASSOC. 693-702 (1996). For example, lipid peroxidation is the initiating
step in the oxidation of low-density lipoproteins (LDL). In turn, the
lipid peroxides oxidate other lipoproteins, which are taken up by the
cells of the arterial wall. Eventually, the deposited oxidized
lipoproteins form an atherosclerotic plaque. Id. The antioxidant
components of the compositions and methods described herein may
preferably include one or more of vitamin E, selenium, vitamin C,
carotenoids, lutein, and lipoic acid.

[0035]The compositions and methods of the present invention may also
include B-complex vitamins, which are critical for health as each is part
of one or more coenzymes in metabolizing food properly. This class of
vitamins is water-soluble nutrients, not stored significantly in the
body. Importantly, the B-complex vitamins may help normalize homocysteine
levels and metabolism. High homocysteine levels have been correlated
directly with increased risk of atherosclerosis and other heart disease.
Although the exact mechanism by which homocysteine contributes to heart
disease is not fully understood, it may act as an endothelial irritant
that promotes atherosclerosis.by inducing endothelial dysfunction.
B-complex vitamins are required for the proper function of the
homocysteine metabolic pathway, thus maintaining adequate levels of these
vitamins may assist in normalizing homocysteine levels and maintaining
good health. The B-complex vitamins of the present compositions and
methods may preferably include one or more of thiamin (B1), riboflavin
(B2), niacin (B3), pantothenic acid (B5), biotin, folic acid, pyridoxine
(B6) and cobalamin (B12).

[0036]Minerals are inorganic, or non-carbon-containing, elements that are
critical for healthy physiological processes, and are contemplated in the
compositions and methods of the present invention. For example, minerals
act as cofactors for hundreds of enzymes that range from those
associated, for example, with food digestion, nucleic acid production,
protein synthesis to antioxidant enzymes. One particular mineral,
chromium, is essential in healthy insulin function, as it plays a direct
role in insulin's interactions at the cellular level. The minerals of the
compositions and methods of the present invention may preferably include
one or more of chromium, zinc, copper, magnesium, and manganese.

[0037]The compositions and methods of the present invention may also
include vitamin D. Specifically, the compositions and methods of the
present invention may include a beneficially increased supplementation of
vitamin D. Vitamin D is a fat-soluble "hormone like" substance essential
for healthy bones. This vitamin increases the absorption of calcium and
phosphorous from the gastrointestinal tract, and improves essential
mineral resorption into bone tissue. Vitamin D can be converted to its
active form from exposure of the skin to sunlight. Clemens et al., 1
LANCET. 74-76 (1982); Maclaughlin et al., 76 J CLIN INVEST. 1536-39
(1985). This fact is among the reasons why vitamin D deficiency is common
in the elderly, notably the institutionalized, who spend little or no
time out of doors. Deficiencies lead to increased bone turnover and loss,
and when severe, osteomalacia or softening of the bones. Supplementation
with vitamin D has been shown to moderately reduce bone loss, increase
serum 25-hydroxyvitamin D, and decrease serum parathyroid hormone levels.
Dawson-Hughes et al., 337 NEW ENG. J. MED. 670-76 (1997); Lips et al., 86
J. CLIN. ENDOCRINOL. METAB. 1212-21 (2001).

[0039]Further, studies suggest that an intake of about 1000 IU of vitamin
D3 (cholecalciferol) per day for all adults may bring at least 50% of the
population up to the 30 ng/ml serum range for 25-hydroxyvitamin D. Id.
Current nutritional supplements, however, do not provide a high enough
dosage for obtaining such a high serum level of 25-hydroxyvitamin D.
Presently, the suggested daily amount of vitamin D, as stated by the U.S.
Dietary Reference Intake for adequate intake (AI) of vitamin D for
infants, children and men and women aged 19-50 is 200 IU/day. Adequate
intake increases to 400 IU/day for men and women aged 51-70 and up to 600
IU/day past the age of 70. Id. Due to these studies, present nutritional
supplements may be insufficient to remedy the current U.S. and global
epidemic related to vitamin D deficiency.

[0040]A nutritional supplement that includes a higher dosage amount of
vitamin D in nutritional supplements is therefore currently needed. Thus,
one embodiment of the present invention includes compositions and methods
designed to optimize health and wellness, minimize oxidative stress, and
provide a beneficial increased supplementation of vitamin D.

[0041]In one embodiment of the present invention, vitamin D is present in
an amount more than 480 IU. In another embodiment of the invention,
vitamin D is present in the amount ranging from about 500 IU to about
1500 IU. In another embodiment, vitamin D is present in the amount
ranging from about 750 IU to about 1250 IU. In another embodiment,
vitamin D is present in the amount ranging form about 900 IU to about
1100 IU.

[0042]Preferably, the vitamin D of the compositions and methods of the
present invention is vitamin D3. In the body, vitamin D3 is produced when
its precursor is exposed to ultraviolet irradiation (e.g., sunlight) and
then hydroxylated in the liver to form 25-hydroxyvitamin D3, the major
form of vitamin D in the circulation. This form of the vitamin may be
hydroxylated again in the kidney, yielding 1,25 hydroxyvitamin D3, the
most potent form of vitamin D. As noted above, vitamin D3 plays a role in
the maintenance of calcium and phosphorus homeostasis, but it is also
active in cell differentiation and immune function. In a particularly
preferred embodiment, vitamin D3 is present in a range of about 500 IU to
about 1500 IU. In another particularly preferred embodiment, vitamin D3
is present in an amount of about 1000 IU.

[0044]In a specific embodiment, the compositions and methods of the
present invention may include one or more pharmaceutically acceptable
carriers. In a specific embodiment, a pharmaceutically acceptable carrier
may be selected from one or more of the group consisting of binders,
diluents, lubricants, glidants, colorants, emulsifiers, disintegrants,
starches, water, oils, alcohols, preservatives and sugars. In another
specific embodiment of the present invention, the compositions and
methods may consist of carotenoids, vitamin E, more than 480 IU vitamin
D, vitamin C, Colic acid, vitamin B6, vitamin B12, vitamin B1, vitamin
B2, vitamin B3, vitamin B5, biotin, magnesium, manganese, zinc, selenium,
chromium, copper, alpha lipoic acid, lutein and one or more
pharmaceutically acceptable carriers.

[0046]Vitamin E is a fat-soluble vitamin antioxidant found in biological
membranes where it protects the phospholipid membrane from oxidative
stress. More specifically, alpha-tocopherol, the most abundant and most
active form of the vitamin E family, is the principle lipid-soluble,
chain breaking antioxidant in tissue and plasma. RECOMMENDED DIETARY
ALLOWANCES 99-101 (Nat'l Research Council, 10th ed., 1989) (hereinafter
"RDA"). Vitamin E inhibits the oxidation of unsaturated fatty acids by
trapping peroxyl free radicals. It is also an antiatherogenic agent, and
studies have demonstrated a reduced risk of coronary heart disease with
increased intake of vitamin E. Stampfer et al., 328 New Eng. J. MED.
1444-49 (1993). Vitamin E is available in various forms known to those of
skill in the art. In a specific embodiment of the present invention,
vitamin E is present in an amount ranging from about 50 IU to about 150
IU. In another embodiment, vitamin E is present in an amount ranging from
about 75 IU to about 125 IU. In another embodiment, vitamin E is present
in an amount ranging from about 90 IU to about 110 IU. In another
specific embodiment of the invention, vitamin E is present in an amount
of about 100 IU. In another specific embodiment of the invention, vitamin
E is present as d-alpha tocopheryl succinate. A specific embodiment of
the invention includes about 100 IU d-alpha tocopheryl succinate.

[0047]Along with vitamin E, the mineral selenium is a component of the
antioxidant enzyme, glutathione peroxidase, which plays a critical role
in the control of oxygen metabolism, particularly catalyzing the
breakdown of hydrogen peroxide. Burk, 3 ANN. REV. NUTRITION 53-70 (1983).
Glutathione peroxidase prevents the generation of free radicals and
decreases the risk of oxidative damage to numerous tissues, including the
vascular system. Holben, 99 J. AM. DIETARY ASSOC. 836-43 (1999). Another
selenoprotein is the enzyme iodothyronine 5'-diodinase that converts
thyroxine (T4) to triiodothyronine (T3). Selenium is available
in many forms known to those of ordinary skill in the art. In a preferred
embodiment of the present invention, selenium is included in an amount
ranging from about 50 μg to about 150 μg. In another embodiment,
selenium is present in an amount ranging from about 75 μg to about 125
μg. In another embodiment, selenium is present in an amount ranging
from about 90 μg to about 110 μg. In another specific embodiment of
the invention, selenium is present in an amount of about 100 μg. In a
specific embodiment of the invention, selenium is present as sodium
selenate. A specific embodiment of the invention includes about 100 μg
sodium selenate.

[0048]Vitamin C (also known as ascorbic acid) is another antioxidant
present in the invention described herein. The major biochemical role of
the water-soluble vitamin C is as a co-substrate in metal catalyzed
hydroxylations, and it has antioxidant properties in interacting directly
with superoxide hydroxyl radicals and singlet oxygen. Vitamin C also
provides antioxidant protection for folate and vitamin E, keeping vitamin
E in its most potent form. It also enhances the absorption of iron. RDA,
at 115. In addition, vitamin C is required for collagen synthesis,
epinephrine synthesis, and bile acid formation. Moreover, vitamin C has
been implicated in inhibiting atherosclerosis by being present in
extracellular fluid of the arterial wall and potentiating nitric oxide
activity, thus normalizing vascular function. A specific embodiment of
the compositions of the present invention includes a supplemental dose of
vitamin C, preferably in the range of about 150 mg to about 450 mg. In
another embodiment, vitamin C may be present in the range of about 225 mg
to about 375 mg. In another embodiment of the present invention, vitamin
C may be present in the range of about 270 mg to about 330 mg. A specific
embodiment of the present invention includes vitamin C in the amount of
about 300 mg.

[0049]Along with vitamins E and C, and selenium, carotenoids are a group
of antioxidants embodied in the present invention. There are over 600
carotenoids occurring naturally in fruits and vegetables. Many of these
fat-soluble compounds, of which beta-carotene is a well-known example,
have pro-vitamin A activity as well as antioxidant activity. Less-known
carotenoids include alpha-carotene, lutein, cryptoxanthine, and
zeaxanthin. The compositions and methods herein include a cartonoid
complex that closely mirrors that found naturally in fruits and
vegetables. In particular, the carotenoids of the present invention may
include alpha-carotene, beta-carotene, cryptoxanthin, lutein, and
zeaxanthin. In particular, lutein and zeaxanthin are the major
carotenoids that make up the macular pigment of the eye's retina, and
their antioxidant properties protect the eye from light-induced. damage
and macular degeneration. Berendschot et al., 41 INVEST. OPHTHALMOL. VIS.
SCI. 3322-26 (2000). In a specific embodiment of the invention,
carotenoids may be included in a range of about 1500 IU to about 4500 IU.
In another embodiment of the invention, carotenoids may be present in a
range of about 2250 IU to about 3750 IU. In another embodiment of the
invention, carotenoids may be present in a range of about 2700 IU to
about 3300 IU. In another embodiment of the invention, carotenoids may be
present in an amount of about 3000 IU. In a more specific embodiment of
the invention, the carotenoids include a mixture of alpha-carotene,
beta-carotene, cryptoxanthin, lutein, and zeaxanthin. A specific
embodiment of the invention includes about 3000 IU of a mixture of
alpha-carotene, beta-carotene, cryptoxanthin, lutein, and zeaxanthin. In
another specific embodiment, the carotenoids may include lutein and
zeaxanthin.

[0050]Lutein is also preferably included in the compositions and methods
described herein and is preferably included in an amount distinguished
from that included in the mixed carotenoids. Regarding the antioxidant
activity of lutein, scientists have demonstrated that lutein is an
effective antioxidant capable of scavenging peroxyl radicals and
quenching reactive oxygen species. Rapp et al., 41 INVEST. OPHTHALMOL.
VIS. SCI. 1200-09 (2000). Thus, the compositions and methods of the
present invention may include lutein, preferably in the amount ranging
from about 2.5 mg to about 7.5 mg. In another embodiment, lutein may be
present in the amount ranging from about 3.75 mg to about 6.25 mg. In
another embodiment, lutein may be present in the amount ranging from
about 4.5 mg to about 5.5 mg. A specific embodiment of the invention
includes the amount of about 5 mg lutein.

[0051]Lipoic acid is an antioxidant and is preferably included in the
compositions and methods of the present invention. Known as the
"universal antioxidant," alpha lipoic acid is both a lipid- and
water-soluble antioxidant that works synergistically with other
antioxidants in the cell's mitochondria. In addition to working with
other antioxidant nutrients, lipoic acid has powerful, pro-antioxidant
enzyme properties. Alpha lipoic acid is also a cofactor for several
regulatory enzymes, including pyruvate dehydrogenase, and appears to have
an effect on glucose transport and utilization. Rudich et al., 42
DIABETOLOGIA 949-57 (1999). Alpha lipoic acid also increases tocopherol
activity and acts as a metal chelator. Furthermore, alpha lipoic acid
improves microvascular perfusion. Haak et al., 108 EXPERIMENTAL &
CLINICAL ENDOCRINOLOGY & DIABETES 168-74 (2000). In a specific embodiment
of the compositions and methods of the present invention, alpha lipoic
acid may be present in the amount ranging from about 7.5 mg to about 22.5
mg. In another embodiment, alpha lipoic acid may be present in the amount
of about 18.75 mg to about 11.25 mg. In another embodiment, alpha lipoic
acid may be present in the amount of about 13.5 mg to about 16.5 mg. A
specific embodiment of the present invention may include alpha lipoic
acid in the amount of about 15 mg.

[0052]In addition to antioxidants, the compositions and methods of the
present invention also preferably include one or more B-complex vitamins
such as thiamin (B1), riboflavin (B2), niacin (B3), pantothenic acid
(B5), biotin, folic acid, pyridoxine (B6) and cobalamin (B12).

[0053]Thiamine (vitamin B1) plays a role in carbohydrate metabolism and
neural function. It is a coenzyme for the oxidative decarboxylation of
alpha-ketoacids (e.g., alpha-ketoglutarate and pyruvate) and for
transketolase which is a component of the pentose phosphate pathway.
Folate deficiency and malnutrition inhibit the activity of thiamine. RDA,
at 123. One embodiment of the compositions of the present invention may
include thiamin. In one embodiment, thiamin may be present in the amount
ranging from about 10 mg to about 30 mg. In another embodiment, thiamin
may be present in the amount ranging from about 15 mg to about 25 mg. In
another embodiment, thiamin may be present in the amount ranging from
about 18 mg to about 22 mg. In another embodiment, thiamin may be present
in the amount of about 20 mg. In a specific embodiment of the present
invention, the form of thiamine is thiamine HCl. Another specific
embodiment of the invention comprises about 20 mg thiamine HCl.

[0054]Riboflavin (vitamin B2) is a component of two flavin coenzymes,
flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD). These
flavoenzymes are involved in a number of oxidation-reduction reactions
including the conversion of pyridoxine and niacin. RDA, at 132.
Flavoenzymes also play a role in a number of metabolic pathways such as
citric acid cycle, amino acid deamination, purine degradation, and fatty
acid oxidation and thus help to maintain carbohydrate, amino acid, and
lipid metabolism. In one embodiment, the compositions and methods of the
present invention may include riboflavin. In one embodiment, riboflavin
may be present in the amount ranging from about 2.5 mg to about 7.5 mg.
In another embodiment, riboflavin may be present in the amount ranging
from about 3.75 mg to about 6.25 mg. In another embodiment, riboflavin
may be present in the amount ranging from about 4.5 mg to about 5.5 mg.
In another embodiment, riboflavin may be present in the amount of about 5
mg.

[0055]Niacin, also called vitamin B3, is the common name for two
compounds: nicotinic acid (also called niacin) and niacinamide (also
called nicotinamide). Niacin and is particularly important for
maintaining healthy levels and types of fatty acids. Niacin is also
required for the synthesis of pyroxidine, riboflavin, and folic acid.
RDA, at 137. Administration of niacin may also produce a reduction in
total cholesterol, LDL, and very low density lipoprotein (VLDL) levels;
and an increase in high density lipoprotein (HDL) cholesterol levels.
Nicotinamide adenine dinucleotide (NAD) and NAD phosphate (NADP) are
active coenzymes of niacin. These coenzymes are involved in numerous
enzymatic reactions such as glycolysis, fatty acid metabolism, and
steroid synthesis. Henkin et al., 91 AM. J. MED. 239-46 (1991). One
embodiment of the compositions and methods of the present invention may
include niacin. In one embodiment, niacin may be present in the amount
ranging from about 12.5 mg to about 37.5 mg. In another embodiment,
niacin may be present in the amount ranging from about 18.75 mg to about
31.25 mg. In another embodiment, niacin may be present in the amount
ranging from about 22.5 mg to about 27.5 mg. In another embodiment,
niacin may be present in the amount of about 25 mg. In a preferred
embodiment of the invention, niacin is present in the form of
niacinamide. A specific embodiment of the invention includes about 25 mg
of niacinamide.

[0056]Folic acid (vitamin B9), also called folate or methylfolate, is
essential for the formation of red and white blood cells within bone
marrow and also plays a role in heme formation. RDA, at 150. Folic acid
in its active form, tetrahydrofolate, is a coenzyme that is involved in
the transfer of methyl groups and it plays a role in DNA synthesis,
purine synthesis, and amino acid synthesis, such as the conversion of
glycine to serine and the transformation of homocysteine to methionine.
The activation of folic acid requires a vitamin B12-dependent
transmethylation and vitamin B12 is also necessary for folic acid
delivery to tissues. Id. One embodiment of the compositions and methods
of the present invention may comprise folic acid. In one embodiment of
the present invention, folic acid may be present in the amount ranging
from about 0.5 mg to about 1.5 mg. In another embodiment of the present
invention, folic acid may be present in the amount ranging from about
0.75 mg to about 1.25 mg. In another embodiment of the present invention,
folic acid may be present in the amount ranging from about 0.9 mg to
about 1.1 mg. In another embodiment of the invention, folic acid may
present in the amount of about 1 mg.

[0057]Pyridoxine (vitamin B6) is another B-complex vitamin included in the
compositions and methods described herein. The administration of
pyridoxine may reduce the levels of homocysteine. Bostom et al., 49
KIDNEY INT. 147-52 (1996). The active forms of pyridoxine,
pyridoxal-5'-phosphate (PLP) and pyridoxamine-5'-phosphate, are coenzymes
for numerous enzymes and as such, are essential for gluconeogenesis,
niacin formation, and erythrocyte metabolism. RDA, at 142-143. Pyridoxine
is a coenzyme for both cystathionine synthase and cystathionase, enzymes
that catalyze the formation of cysteine from methionine. Homocysteine is
an intermediate in this process and elevated levels of plasma
homocysteine are recognized as a risk factor for vascular disease.
Robinson et al., 94 CIRCULATION 2743-48 (1996). Hence, one embodiment of
the compositions and methods of the present invention may include
pyridoxine. In one embodiment of the present invention, pyridoxine may be
present in the amount ranging from about 12.5 mg to about 37.5 mg. In
another embodiment of the present invention, pyridoxine may be present in
the amount ranging from about 18.75 mg to about 31.25 mg. In another
embodiment of the present invention, pyridoxine may be present in the
amount ranging from about 22.5 mg to about 27.5 mg. In another
embodiment, pyridoxine may be present in the amount of about 25 mg. In a
specific embodiment of the invention, pyridoxine is in the form of
pyridoxine HCl. A specific embodiment of the invention includes about 25
mg pyridoxine HCl.

[0058]Biotin, another water-soluble B-complex vitamin, acts a coenzyme for
a number of carboxylases, and thus has an important role in
gluconeogenesis, fatty acid metabolism, and amino acid metabolism. RDA,
at 166. For example, biotin serves as a carboxyl carrier for pyruvate
carboxylase, which is involved in gluconeogenesis; acetyl CoA
carboxylase, which is involved in fatty acid synthesis; and propionyl-CoA
carboxylase, which is involved in glucose production. Researchers believe
that biotin inhibits the effects of uremic toxins on tubulin
polymerizaton. Braguer et al., 57 NEPHRON 192-96 (1991). Thus, one
embodiment of the compositions and methods of the present invention may
include biotin. In one embodiment of the present invention, biotin may be
present in the amount ranging from about 50 μg to about 150 μg. In
another embodiment of the present invention, biotin may be present in the
amount ranging from about 75 μg to about 125 μg. In another
embodiment of the present invention, biotin may be present in the amount
ranging from about 90 μg to about 110 μg. In another embodiment of
the present invention, biotin may be present in the amount of about 100
μg.

[0059]Pantothenic acid (vitamin B5) is a component of both the coenzyme A
macromolecule and the acyl-carrier protein. These coenzymes function as
carriers for acyl groups and are required for the synthesis of fatty
acids, cholesterol, steroid hormones, and neurotransmitters. The coenzyme
A complex also has a major role in the acetylation and acylation of
numerous proteins. RDA, at 169. One embodiment of the compositions and
methods of the present invention may include pantothenic acid. In one
embodiment of the present invention, pantothenic acid may be present in
the amount ranging from about 7.5 mg to about 22.5 mg. In another
embodiment of the present invention, pantothenic acid may be present in
the amount ranging from about 11.25 mg to about 18.75 mg. In another
embodiment of the present invention, pantothenic acid may be present in
the amount ranging from about 13.5 mg to about 16.5 mg. In another
embodiment of the present invention, pantothenic acid may be present in
the amount of about 15 mg. In a specific embodiment of the invention,
pantothenic acid is present as calcium pantothenate. A specific
embodiment of the invention includes about 15 mg calcium pantothenate.

[0060]Cobalamin (vitamin B12), another important vitamin included in the
compositions and methods described herein, can be converted to the active
coenzymes, methylcobalamin and 5'-deoxyadenosylcobalamin. These coenzymes
are necessary for folic acid metabolism, conversion of coenzyme A, and
myelin synthesis. For example, methylcobalamin catalyzes the
demethylation of a folate cofactor, which is involved in DNA synthesis. A
lack of demethylation may result in folic acid deficiency. RDA, at
159-160. Deoxyadenosylcobalamin is the coenzyme for the conversion of
methylmalonyl-CoA to succinyl-CoA, which plays a role in the citric acid
cycle. Importantly, cobalamin, along with pyridoxine and folic acid in
implicated in the proper metabolism of homocysteine. Cobalamin is
available as cyanocobalamin, methylcobalamin, hydroxocobalamin,
adenosylcobalamin, and hydroxycyanocobalamin. One embodiment of the
compositions and methods of the present invention may include cobalamin.
In one embodiment of the present invention, cobalamin may be present in
the amount ranging from about 25 μg to about 75 μg. In another
embodiment, cobalamin may be present in the amount ranging from about
37.5 μg to about 62.5 μg. In another embodiment, cobalamin may be
present in the amount ranging from about 45 μg to about 55 μg. In
one embodiment of the present invention, cobalamin may be present in the
amount of about 50 μg. In a specific embodiment of the invention,
cobalamin is present as cyanocobalamin. Another specific embodiment of
the invention includes about 50 μg cyanocobalamin.

[0061]As noted previously, minerals are inorganic elements that play a
crucial role in physiological processes in the body relating to good
health. The compositions and methods of the present invention may
comprise minerals, and, in a preferred embodiment, comprise one or more
of selenium, discussed above, and magnesium, manganese, zinc, chromium,
and copper.

[0062]Magnesium is found primarily in both bone and muscle. Magnesium is
an essential component for over 300 enzymes, including enzymes of
biosynthetic pathways, glycolysis, protein synthesis, transketolase
reactions, and membrane transport. Magnesium is also involved in the
formation of cAMP, a cytosolic second messenger that plays a role in cell
signaling mechanisms. In addition, magnesium functions both
synergistically and antagonistically with calcium in neuromuscular
transmission. RDA, at 188. Specifically, magnesium is critical for the
maintenance of electrochemical potentials of nerve and muscle membranes
and the neuromuscular junction transmissions, particularly important in
the heart. Not surprisingly, magnesium deficiency is tied to
cardiovascular disease and hypertension. Agus et al., 17 CRIT. CARE
CLINICS 175-87 (2001). Indeed, oral magnesium therapy improves
endothelial function in patients with coronary disease. Shechter et al.,
102 CIRCULATION 2353-58 (2000). Yet, most individuals in the U.S. receive
only about seventy-five percent of the magnesium they need from their
diets. Magnesium is available in a variety of salts. One embodiment of
the compositions and methods of the present invention may include
magnesium. In one embodiment of the present invention, magnesium may be
present in the amount ranging from about 25 mg to about 75 mg. In another
embodiment of the present invention, magnesium may be present in the
amount ranging from about 37.5 mg to about 62.5 mg. In another embodiment
of the present invention, magnesium may be present in the amount ranging
from about 45 mg to about 55 mg. In one embodiment of the present
invention, magnesium may be present in the amount of about 50 mg. In a
specific embodiment of the invention, magnesium may be present as
magnesium oxide. A specific embodiment of the invention includes about 50
mg magnesium oxide.

[0063]Manganese, like magnesium, plays a key role in multiple enzymes and
is needed for healthy skin, bone, and cartilage formation, as well as
glucose tolerance. For example, manganese is a cofactor for enzymes such
as glutamine synthetase, pyruvate carboxylase, and mitochrondrial
superoxide dismutase. RDA, at 230. In particular, manganese is essential
for glycoprotein and proteoglycan synthesis, and thus is involved in the
formation of connective and skeletal tissue, as well as carbohydrate and
lipid metabolism. It also helps activate superoxide dismutase, an
important antioxidant enzyme. Manganese is available in many forms known
to those of ordinary skill in the art, including manganese sulfate,
manganese oxide, manganese oxy-sulfate, and manganese proteinate. One
embodiment of the compositions and methods of the present invention may
include manganese. In one embodiment of the present invention, manganese
may be present in the amount ranging from about 0.75 mg to about 2.25 mg.
In another embodiment of the present invention, manganese may be present
in the amount ranging from about 1.125 mg to about 1.875 mg. In another
embodiment of the present invention, manganese may be present in the
amount ranging from about 1.35 mg to about 1.65 mg. In one embodiment of
the present invention, manganese may be present in the amount of about
1.5 mg. In a specific embodiment, manganese is present as manganese
sulfate. A specific embodiment of the invention includes about 1.5 mg of
manganese sulfate.

[0064]Zinc plays a role in numerous metabolic activities such as nucleic
acid production, protein synthesis, and development of the immune system.
There are more than 200 zinc metalloenzymes including aldolase, alcohol
dehydrogenase, RNA polymerase, and protein kinase C. Zima et al., 17
BLOOD PURIF. 182-86 (1999). Moreover, zinc stabilizes RNA and DNA
structures, forms zinc fingers in nuclear receptors, and is a component
of chromatin proteins involved in transcription and replication. Zinc is
available in many forms, such as zinc oxide and zinc sulfate. One
embodiment of the compositions and methods of the present invention may
include zinc. In one embodiment of the present invention, zinc may be
present in the amount ranging from about 12.5 mg to about 37.5 mg. In
another embodiment of the present invention, zinc may be present in the
amount ranging from about 18.75 mg to about 31.25 mg. In one embodiment
of the present invention, zinc may be present in the amount of about 25
mg. In a specific embodiment, zinc may be present as zinc oxide. Another
specific embodiment of the present invention includes about 25 mg zinc
oxide.

[0065]The trace mineral chromium harmonizes with insulin at the cellular
level to optimize the release of energy from glucose, as well as
maintaining proper cellular lipid or fat metabolism. Specifically,
chromium increases insulin binding to cells, insulin receptor number, and
activates the insulin receptor kinase leading to increased insulin
sensitivity. Several studies suggest that adequate chromium levels are
needed for optimal glycemic control. See, e.g., Anderson et al., 26
DIABETES METABOLABOLISM 22-27 (2000); Vincent, 130 J. NUTRITION 715-18
(2000). The concentration of chromium declines with age, and coronary
artery disease appears to be associated with low levels of chromium. RDA,
at 241. Yet, ninety percent of adults in the U.S. consume less than the
recommended minimum amount of chromium. Chromium is available in various
forms known to those skilled in the art, such as chromium chloride,
chromium sulfate, chromium potassium sulfate, and chromium picolinate.
One embodiment of the compositions and methods of the present invention
may include chromium. In one embodiment of the present invention,
chromium may be present in the amount ranging from about 25 μg to
about 75 μg. In another embodiment of the present invention, chromium
may be present in the amount ranging from about 37.5 μg to about 62.5
μg. In another embodiment of the present invention, chromium may be
present in the amount ranging from about 45 μg to about 55 μg. In
one embodiment of the present invention, chromium may be present in the
amount of about 50 μg. Specifically, chromium may be supplied as
chromium chloride. A specific embodiment of the invention includes about
50 μg chromium chloride.

[0066]Copper is a component of several enzymes associated with numerous
physiological functions, including, for example, oxidase enzymes, such as
cytochrome c oxidase, and cytosolic superoxide dismutase. RDA, at 224. In
particular, copper is a cofactor of lysyl oxidase, which is critical for
lysine cross-linking in collagen and elastin. Copper acts as an
antioxidant, and promotes the synthesis of melanin and catecholamines. In
addition, copper is present in the blood as ceruloplasmin which is
involved in oxidizing iron prior to transport to the plasma. Copper is
available in multiple forms, such as cupric oxide, copper sulfate, cupric
acetate, and alkaline copper carbonate. One embodiment of the
compositions and methods of the present invention may include copper. In
one embodiment of the present invention, copper may be present in the
amount ranging from about 0.75 mg to about 2.25 mg. In another embodiment
of the present invention, copper may be present in the amount ranging
from about 1.125 mg to about 1.875 mg. In another embodiment of the
present invention, copper may be present in the amount ranging from about
1.35 mg to about 1.65 mg. In one embodiment of the present invention,
copper may be present in the amount of about 1.5 mg. In a specific
embodiment of the invention, copper may be present as cupric sulfate. A
specific embodiment includes about 1.5 mg cupric sulfate.

[0068]In another embodiment, the present invention may include
compositions and methods of ranges or amounts of the vitamins, minerals,
nutrients and antioxidants. In another specific embodiment, the
compositions and methods of the present invention may include about 1500
IU to about 4500 IU carotenoids, about 50 IU to about 150 IU vitamin E,
about 500 IU to about 1500 IU vitamin D3, about 150 mg to about 450 mg
vitamin C, about 0.5 mg to about 1.5 mg folio acid, about 12.5 mg to
about 37.5 mg pyridoxine, about 25 μg to about 75 μg cobalamin,
about 10 mg to about 30 mg thiamin, about 2.5 mg to about 7.5 mg
riboflavin, about 12.5 mg to about 37.5 mg niacin, about 7.5 mg to about
22.5 mg pantothenic acid, about 50 μg to about 150 μg biotin, about
25 mg to about 75 mg magnesium, about 0.75 mg to about 2.25 mg manganese,
about 12.5 mg to about 37.5 mg zinc, about 50 μg to about 150 μg
selenium, about 25 μg to about 75 μg chromium, about 0.75 mg to
about 2.25 mg copper, about 7.5 mg to about 22.5 mg alpha lipoic acid,
and about 2.5 mg to about 7.5 mg lutein. In another specific embodiment,
the compositions and methods of the present invention may comprise about
1500 IU to about 4500 IU carotenoids, about 50 IU to about 150 IU vitamin
E, about 500 IU to about 1500 IU vitamin D3, about 150 mg to about 450 mg
vitamin C, about 0.5 mg to about 1.5 mg folio acid, about 12.5 mg to
about 37.5 mg pyridoxine, about 25 μg to about 75 μg cobalamin,
about 10 mg to about 30 mg thiamin, about 2.5 mg to about 7.5 mg
riboflavin, about 12.5 mg to about 37.5 mg niacin, about 7.5 mg to about
22.5 mg pantothenic acid, about 50 μg to about 150 μg biotin, about
25 mg to about 75 mg magnesium, about 0.75 mg to about 2.25 mg manganese,
about 12.5 mg to about 37.5 mg zinc, about 50 μg to about 150 μg
selenium, about 25 μg to about 75 μg chromium, about 0.75 mg to
about 2.25 mg copper, about 7.5 mg to about 22.5 mg alpha lipoic acid,
and about 2.5 mg to about 7.5 mg lutein. In another specific embodiment,
the compositions and methods of the present invention may consist
essentially of about 1500 IU to about 4500 IU carotenoids, about 50 IU to
about 150 IU vitamin E, about 500 IU to about 1500 IU vitamin D3, about
150 mg to about 450 mg vitamin C, about 0.5 mg to about 1.5 mg folic
acid, about 12.5 mg to about 37.5 mg pyridoxine, about 25 μg to about
75 μg cobalamin, about 10 mg to about 30 mg thiamin, about 2.5 mg to
about 7.5 mg riboflavin, about 12.5 mg to about 37.5 mg niacin, about 7.5
mg to about 22.5 mg pantothenic acid, about 50 μg to about 150 μg
biotin, about 25 mg to about 75 mg magnesium, about 0.75 mg to about 2.25
mg manganese, about 12.5 mg to about 37.5 mg zinc, about 50 μg to
about 150 μg selenium, about 25 μg to about 75 μg chromium,
about 0.75 mg to about 2.25 mg copper, about 7.5 mg to about 22.5 mg
alpha lipoic acid, and about 2.5 mg to about 7.5 mg lutein. In another
specific embodiment, the compositions and methods of the present
invention may consist of about 1500 IU to about 4500 IU carotenoids,
about 50 IU to about 150 IU vitamin E, about 500 IU to about 1500 IU
vitamin D3, about 150 mg to about 450 mg vitamin C, about 0.5 mg to about
1.5 mg folic acid, about 12.5 mg to about 37.5 mg pyridoxine, about 25
μg to about 75 μg cobalamin, about 10 mg to about 30 mg thiamin,
about 2.5 mg to about 7.5 mg riboflavin, about 12.5 mg to about 37.5 mg
niacin, about 7.5 mg to about 22.5 mg pantothenic acid, about 50 μg to
about 150 μg biotin, about 25 mg to about 75 mg magnesium, about 0.75
mg to about 2.25 mg manganese, about 12.5 mg to about 37.5 mg zinc, about
50 μg to about 150 μg selenium, about 25 μg to about 75 μg
chromium, about 0.75 mg to about 2.25 mg copper, about 7.5 mg to about
22.5 mg alpha lipoic acid, about 2.5 mg to about 7.5 mg lutein and one or
more pharmaceutically acceptable carriers.

[0072]The compositions and methods of the present invention represent a
combination of essential vitamins and minerals that work together with
various metabolic systems and physiological responses of the human body.
The active ingredients are available from numerous commercial sources,
and in several active forms or salts thereof, known to those of ordinary
skill in the art. Hence, the compositions and methods of the present
invention are not limited to any particular form of the vitamin or
mineral ingredient described herein.

[0073]While supplementation with certain vitamins, antioxidants, nutrients
and minerals protects against the onset of these diseases, other vitamins
and minerals have been found to inhibit the beneficial effects of these
certain vitamins, antioxidants, minerals and other nutrients. Thus, in a
specific embodiment, the compositions and methods of the present
invention may be substantially free of other added vitamins,
antioxidants, minerals and nutrients. In a more specific embodiment, the
compositions and methods of the present invention may be substantially
free of all other added vitamins, minerals and nutrients except for
carotenoids, vitamin E, vitamin D, vitamin C, folic acid, vitamin B6,
vitamin B12, vitamin B1, vitamin B2, vitamin B3, vitamin B5, biotin,
magnesium, manganese, zinc, selenium, chromium, copper, alpha lipoic
acid, lutein and their equivalents.

[0074]B-complex vitamins, such as vitamins B6 and B12, vitamin D3, and
magnesium play integral roles in physiological mechanisms that serve to
prevent, treat and/or alleviate the occurrence or negative effects of
cardiovascular disease, colorectal cancer and osteoporosis.
Supplementation with vitamins and minerals such as vitamin A, vitamin K,
and iron may inhibit these beneficial effects. Thus, when creating or
choosing a nutritional supplement, it is essential to understand the
physiological needs and risks of individual patients and population
groups and the interactions between various vitamins and minerals.

[0075]For example, vitamin A may inhibit the beneficial effects of the
present invention. Supplementation with vitamins and minerals such as
vitamin A, may inhibit the beneficial effects of the B-complex vitamins,
vitamin D3, and magnesium. Moreover, elevated serum levels of the
active form of vitamin A (retinol) are correlated with increased bone
fragility with a resulting deleterious effect on bone health. Although
retinol is involved in bone remodeling, excessive intake, as can occur
with long term supplementation, has been linked to bone demineralization.
Michaelson et al., 348(4) N. ENG. J. MED. 287-94 (2003); Feskanich et
al., 287(1) JAMA 47-54 (2002). In a specific embodiment, the compositions
and methods of the present invention may be substantially free of added
vitamin A.

[0076]Another example of a vitamin that may have deleterious effects is
vitamin K. Although vitamin K, or phylloquinone, plays a role in the
process of maintaining bone health, it also plays a major role in the
synthesis of coagulation factors. This delicate balance of coagulation is
at times purposefully altered in those with, or at high risk of,
cardiovascular disease. Increased intake of vitamin K can alter the
efficacy of specific medications used for this purpose. Further, the
human body produces vitamin K from naturally occurring intestinal
bacteria, thus making deficiency of this nutrient rare. Due to these
factors, broad spectrum vitamin K supplementation is discouraged. Kumik
et al., 37(11) ANN. PHARMACOTHER. 1603-06(2003); Shearer, 345 LANCET
229-34 (1995). In a specific embodiment, the compositions and methods of
the present invention may be substantially free of added vitamin K.

[0077]The mineral iron may be specifically excluded from the compositions
and methods of the present invention. Although iron is an essential
mineral with many functions, iron has also been implicated as a catalyst
for lipid oxidation. Specifically, lipid oxidation associated with LDL
cholesterol has been correlated strongly with an increased risk of
cardiovascular disease. Moreover, some older patients exhibit sensitivity
to iron or build-up of iron concentration in the liver. Although iron
supplementation may be indicated in specific population groups or disease
states, universal supplementation may not always be recommended. Hence,
the compositions and methods of the present invention may be
substantially free of added iron.

[0078]In another example, Lactose is a disaccharide, or sugar that is
found mainly in milk and dairy products. Lactose intolerance or the
inability to properly digest and absorb this compound is relatively
common. With this inability comes uncomfortable side effects such as
abdominal bloating, pain, and diarrhea upon ingestion of
lactose-containing foods. Since milk and dairy products are a primary
source of both calcium and lactose, those who are lactose intolerant are
more likely to have insufficient calcium intake and therefore
osteoporosis. DiStefano et al., 122(7) GASTROENTEROL. 1793-99 (2002). In
a specific embodiment, the compositions and methods of the present
invention may be free of added lactose.

[0079]Specific patients may also have unique or rare adverse reactions to
antioxidants, vitamins or minerals added in the compositions of the
present invention. Thus, in particular instances, the compositions and
methods of the present invention may also be substantially free of one or
more of the added specific antioxidants, vitamins, nutrients or minerals
in the present invention. In one embodiment, the compositions and methods
of the present invention may be substantially fee of added vitamin E. In
one embodiment, the compositions and methods of the present invention may
be substantially free of added vitamin C. In one embodiment, the
compositions and methods of the present invention may be substantially
free of added folic acid. In one embodiment, the compositions and methods
of the present invention may be substantially free of added vitamin B6.
In one embodiment, the compositions and methods of the present invention
may be substantially free of added vitamin B12. In one embodiment, the
compositions and methods of the present invention may be substantially
free of added vitamin B1. In one embodiment, the compositions and methods
of the present invention may be substantially free of added vitamin B2.
In one embodiment, the compositions and methods of the present invention
may be substantially free of added vitamin B3. In one embodiment, the
compositions and methods of the present invention may be substantially
free of added vitamin B5. In one embodiment, the compositions and methods
of the present invention may be substantially free of added biotin. In
one embodiment, the compositions and methods of the present invention may
be substantially free of added magnesium. In one embodiment, the
compositions and methods of the present invention may be substantially
free of added manganese. In one embodiment, the compositions and methods
of the present invention may be substantially free of added zinc. In one
embodiment, the compositions and methods of the present invention may be
substantially free of added selenium. In one embodiment, the compositions
and methods of the present invention may be substantially free of added
chromium. In one embodiment, the compositions and methods of the present
invention may be substantially fee of added copper. In one embodiment,
the compositions and methods of the present invention may be
substantially free of added alpha lipoic acid. In one embodiment, the
compositions and methods of the present invention may be substantially
free of added lutein.

[0080]In another specific embodiment, the compositions and methods of the
present invention may be in the form of a kit. In another specific
embodiment, the kits may be utilized for various packaging of the
composition. For example, in a specific embodiment, the present invention
may comprise swallowable compositions packaged in blister packs. Blister
packs as packaging for swollowable compositions are well known to those
of ordinary skill in the art. Blister packs may be made of a transparent
plastic sheet which as been formed to carry a matrix of depression or
blisters. One or more swollowable compositions are received in each
depression or blister. A foil or plastic backing is then adhered across
the plane of the sheet seating the swollowable compositions in their
respective blisters. Examples of materials used for the blister packs
include, but are not limited to, aluminum, paper, polyester, PVC, and
polypropylene. Alternative materials are known to those of ordinary skill
in the art. To remove a swollowable composition, the depression material
is pressed in and the composition is pushed through the backing material.
Multiple blister packs may be placed in an outer package, often a box or
carton for sale and distribution.

[0081]Another specific embodiment of the present invention may comprise
swallowable compositions packaged in bottles. The bottle may be glass or
plastic in form with a pop or screw top cap. Bottle packaging for
compositions in swollowable form are well known to those of ordinary
skill in the art.

[0082]Additionally, the unit dose forms may be individually wrapped,
packaged as multiple units on paper strips or in vials of any size,
without limitation. The swallowable, chewable or dissolvable compositions
of the invention may be packaged in unit dose, rolls, bulk bottles,
blister packs and combinations thereof, without limitation.

[0083]The ingredients of the present invention are preferably combined
into a composition which may be in the form of a solid powder, caplets,
tablets, lozenges, pills, capsules, softgel or a liquid, and which may be
administered alone or in suitable combination with other components. For
example, the composition of the present invention may be administered in
one or more caplets or lozenges as practical for ease of administration.
Each of the vitamins and minerals is commercially available, and can be
blended to form a single composition or can form multiple compositions,
which may be co-administered.

[0084]To prepare the compositions of the present invention, each of the
active ingredients may be combined in intimate admixture with a suitable
carrier according to conventional compounding techniques. The carrier may
take a wide variety of forms depending upon the form of the preparation
desired for administration, e.g., oral, sublingual, nasal, topical patch,
or parenteral.

[0085]In preparing the composition in oral dosage form, any of the usual
media may be utilized. For liquid preparations (e.g., suspensions,
elixirs, and solutions), media containing, for example water, oils,
alcohols, flavoring agents, preservatives, coloring agents and the like
may be used. Pharmaceutical acceptable carriers such as starches, sugars,
diluents, granulating agents, lubricants, binders, disintegrating agents
and the like may be used to prepare oral solids (e.g., powders, caplets,
pills, tablets, capsules, and lozenges). Controlled release forms may
also be used. Because of their ease in administration, caplets, tablets,
pills, and capsules represent the most advantageous oral dosage unit
form, in which case solid carriers are employed. If desired, tablets may
be sugar coated or enteric coated by standard techniques. All of these
pharmaceutical carriers and formulations are well known to those of
ordinary skill in the art. See, e.g., WADE & WALLER, HANDBOOK OF
PHARMACEUTICAL EXCIPIENTS (2nd ed. 1994).

[0086]In a specific embodiment of the present invention may comprise
compositions in the dosage form of a soft-gel. A soft-gel is a one-piece,
sealed, soft gelatin shell that contains a solution, a suspension, or a
semi-solid paste. Soft-gels are predominantly used to contain liquids
wherein the active ingredients are present in the dissolved or suspended
state. Soft-gels have been widely known and used for many years and for a
variety of purposes. Because soft-gels have properties that are quite
different from two-piece, hard shell capsules, the soft-gels are capable
of retaining a liquid fill material. Soft-gels are often used to
encapsulate consumable materials, including vitamins, dietary
supplements, pharmaceuticals, and the like, in a liquid vehicle or
carrier. Soft-gels arc a unique dosage form that can provide distinct
advantages over more traditional dosage forms such as tablets, hard-shell
capsules, and liquids. These advantages include patient compliance and
consumer preference, improved bioavailability, speed of product
development in many cases, shortened manufacturing time, enhanced drug
stability due to less exposure of the active ingredient to oxygen,
excellent dose uniformity, and product differentiation.

[0087]A specific embodiment of the present invention may comprise
swallowable compositions. Swallowable compositions are well known in the
art and are those that do not readily dissolve when placed in the mouth
and may be swallowed whole without any chewing or discomfort. In a
specific embodiment of the present invention the swallowable compositions
may have a shape containing no sharp edges and a smooth, uniform and
substantially bubble free outer coating.

[0088]In a specific embodiment of the swallowable compositions of the
present invention, the surface of the compositions may be coated with a
polymeric film. Such a film coating has several beneficial effects.
First, it reduces the adhesion of the compositions to the inner surface
of the mouth, thereby increasing the patient's ability to swallow the
compositions. Second, the film may aid in masking the unpleasant taste of
certain drugs. Third, the film coating may protect the compositions of
the present invention from atmospheric degradation. Polymeric films that
may be used in preparing the swallowable compositions of the present
invention include vinyl polymers such as polyvinyl pyrrolidone, polyvinyl
alcohol and acetate, cellulosics such as methyl and ethyl cellulose,
hydroxyethyl cellulose and hydroxylpropyl methylcellulose, acrylates and
methacrylates, copolymers such as the vinyl-maleic acid and
styrene-maleic acid types, and natural gums and resins such as zein,
gelatin, shellac and acacia.

[0089]In a specific embodiment of the present invention, the compositions
may comprise chewable compositions. Chewable compositions are those that
have a palatable taste and mouthfeel, are relatively soft and quickly
break into smaller pieces and begin to dissolve after chewing such that
they are swallowed substantially as a solution.

[0090]In order to create chewable compositions, certain ingredients should
be included to achieve the attributes just described. For example,
chewable compositions should include ingredients that create pleasant
flavor and mouthfeel and promote relative softness and dissolvability in
the mouth. The following discussion describes ingredients that may help
to achieve these characteristics.

[0091]In one embodiment, the compositions and methods of the present
invention may have a pleasant or palatable flavor. Palatable flavors may
be achieved by including sweetening agents and/or flavorants. Sweetening
agents that may be included in the compositions of the present invention
include, by way of example and without limitation, sucrose, fructose,
high fructose corn syrup, dextrose, saccharin sodium, maltodextrin,
aspartame, potassium acesulfame, neohesperidin dihydrochalcone,
sucralose, monoammonium glycyrrhizinate, and others known to those of
ordinary skill in the art. As used herein, the term "flavorant" means
natural or artificial compounds used to impart a pleasant flavor and
often odor to a pharmaceutical preparation. Flavorants that may be used
in the present invention include, for example and without limitation,
natural and synthetic flavor oils, flavoring aromatics, extracts from
plants, leaves, flowers, and fruits and combinations thereof. Such
flavorants include, by way of example and without limitation, anise oil,
cinnamon oil, vanilla, vanillin, cocoa, chocolate, natural chocolate
flavor, menthol, grape, peppermint oil, oil of wintergreen, clove oil,
bay oil, anise oil, eucalyptus, thyme oil, cedar leave oil, oil of
nutmeg, oil of sage, oil of bitter almonds, cassia oil; citrus oils, such
as lemon, orange, lime and grapefruit oils; and fruit essences, including
apple, pear, peach, berry, wildberry, date, blueberry, kiwi, strawberry,
raspberry, cherry, plum, pineapple, and apricot. All of these flavorants
are commercially available. In a specific embodiment of the present
invention, flavorants that may be used include natural berry extracts and
natural mixed berry flavor, as well as citric and malic acid. The amount
of flavorants used may depend on a number of factors, including desired
taste characteristics. While not necessary, one or more of these
sweetening agents and/or flavorants also may be included in the chewable
and swallowable compositions of the present invention.

[0092]In addition to having a palatable flavor, chewable compositions also
should have a pleasant mouthfeel. A variety of ingredients can be
included in the compositions of the present invention to enhance
mouthfeel.

[0094]Alkyl polysiloxanes (commercially available polymers sold in a
variety of molecular weight ranges and with a variety of different
substitution patterns) also may be used in the present invention to
enhance the texture, the mouthfeel, or both of the chewable nutritional
supplement compositions described herein. By "enhance the texture" it is
meant that the alkyl polysiloxane improves one or more of the stiffness,
the brittleness, and the chewiness of the chewable supplement, relative
to the same preparation lacking the alkyl polysitoxane. By "enhance the
mouthfeel" it is meant that the alkyl polysiloxane reduces the gritty
texture of the supplement once it has liquefied in the mouth, relative to
the same preparation lacking the alkyl polysiloxane.

[0095]Alkyl polysiloxanes generally comprise a silicon and
oxygen-containing polymeric backbone with one or more alkyl groups
pending from the silicon atoms of the back bone. Depending upon their
grade, they can further comprise silica gel. Alkyl polysiloxanes are
generally viscous oils. Exemplary alkyl polysiloxanes that can be used in
the swallowable, chewable or dissolvable compositions of the present
invention include, by way of example and without limitation, monoalkyl or
dialkyl polysiloxanes, wherein the alkyl group is independently selected
at each occurrence from a C1-C6-alkyl group optionally
substituted with a phenyl group. A specific alkyl polysiloxane that may
be used is dimethyl polysiloxane (generally referred to as simethicone).
More specifically, a granular simethicone preparation designated
simethicone GS may be used. Simethicone GS is a preparation which
contains 30% simethicone USP. Simethicone USP contains not less than
about 90.5% by weight (CH3)3--Si{OSi(CH3)2}CH3
in admixture with about 4.0% to about 7.0% by weight SiO2.

[0096]To prevent the stickiness that can appear in conventional chewable
compositions and to facilitate conversion of the active ingredients to
emulsion or suspension upon taking, the compositions of the present
invention, may further comprise emulsifiers such as, by way of example
and without limitation, glycerin fatty acid ester, sorbitan monostearate,
sucrose fatty acid ester, lecithin and mixtures thereof. In a specific
embodiment, one or more of such emulsifiers may be present in an amount
of about 0.01% to about 5.0%, by weight of the administered compositions.
If the level of emulsifier is lower or higher than the said range, the
emulsification cannot be realized, or wax value will rise.

[0097]Chewable compositions should begin to break and dissolve in the
mouth shortly after chewing begins such that the compositions can be
swallowed substantially as a solution. The dissolution profile of
chewable compositions may be enhanced by including rapidly water-soluble
fillers and excipients. Rapidly water-soluble fillers and excipients
preferably dissolve within about 60 seconds of being wetted with saliva.
Indeed, it is contemplated that if enough water-soluble excipients are
included in the compositions of the present invention, they may become
dissolvable rather than chewable composition forms. Examples of rapidly
water soluble fillers suitable for use with the present invention
include, by way of example and without limitation, saccharides, amino
acids and the like. In a specific embodiment, the saccharide may be a
mono-, di- or oligosaccharide. Examples of saccharides which may be added
to the compositions of the present invention include, by way of example
and without limitation, sorbitol, glucose, dextrose, fructose, maltose
and xylitol (all monosaccharides); and sucrose, lactose, glucose,
galactose and mannitol (all disaccharides). Other suitable saccharides
are oligosaccharides. Examples of oligosaccharides are dextrates and
maltodextrins. Other water soluble excipients that may be used with the
present invention include, by way of example and without limitation,
amino acids such as alanine, arginine, aspartic acid, asparagine,
cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine,
leucine, lysine, methionine, phenylalanine, proline, serine, threonine,
tryptophan, tyrosine and valine.

[0098]Disintegrants also may be included in the compositions of the
present invention in order to facilitate dissolution. Disentegrants,
including permeabilising and wicking agents, are capable of drawing water
or saliva up into the compositions which promotes dissolution from the
inside as well as the outside of the compositions. Such disintegrants,
permeabilising and/or wicking agents that may be used in the present
invention include, by way of example and without limitation, starches,
such as corn starch, potato starch, pre-gelatinized and modified starches
thereof, cellulosic agents, such as Ac-di-sol, montmorrilonite clays,
cross-linked PVP, sweeteners, bentonite, microcrystalline cellulose,
croscarmellose sodium, alginates, sodium starch glycolate, gums, such as
agar, guar, locust bean, karaya, pectin, Arabic, xanthan and tragacanth,
silica with a high affinity for aqueous solvents, such as colloidal
silica, precipitated silica, maltodextrins, beta-cyclodextrins, polymers,
such as carbopol, and cellulosic agents, such as hydroxymethylcellulose,
hydroxypropylcellulose and hydroxyopropylmethylcellulose.

[0099]Finally, dissolution of the compositions may be facilitated by
including relatively small particles sizes of the ingredients used.

[0100]In addition to those described above, any appropriate fillers and
excipients may be utilized in preparing the swallowable, chewable and/or
dissolvable compositions of the present invention so long as they are
consistent with the objectives described herein. For example, binders are
substances used to cause adhesion of powder particles in granulations.
Such compounds appropriate for use in the present invention include, by
way of example and without limitation, acacia, compressible sugar,
gelatin, sucrose and its derivatives, maltodextrin, cellulosic polymers,
such as ethylcellulose, hydroxypropylcellulose, hydroxypropylmethyl
cellulose, carboxymethylcellulose sodium and methylcellulose, acrylic
polymers, such as insoluble acrylate ammoniomethacrylate copolymer,
polyacrylate or polymethacrylic copolymer, povidones, copovidones,
polyvinylalcohols, alginic acid, sodium alginate, starch, pregelatinized
starch, guar gum, polyethylene glycol and others known to those of
ordinary skill in the art.

[0101]Diluents also may be included in the compositions of the present
invention in order to enhance the granulation of the compositions.
Diluents can include, by way of example and without limitation,
microcrystalline cellulose, sucrose, dicalcium phosphate, starches,
lactose and polyols of less than 13 carbon atoms, such as mannitol,
xylitol, sorbitol, maltitol and pharmaceutically acceptable amino acids,
such as glycin, and their mixtures.

[0102]Lubricants are substances used in composition formulations that
reduce friction during composition compression. Lubricants that may be
used in the present invention include, by way of example and without
limitation, stearic acid, calcium stearate, magnesium stearate, zinc
stearate, talc, mineral and vegetable oils, benzoic acid, poly(ethylene
glycol), glyceryl behenate, stearyl fumarate, and others known to those
of ordinary skill in the art.

[0103]Glidants improve the flow of powder blends during manufacturing and
minimize composition weight variation. Glidants that may be used in the
present invention include, by way of example and without limitation,
silicon dioxide, colloidal or fumed silica, magnesium stearate, calcium
stearate, stearic acid, cornstarch, talc and others known to those of
ordinary skill in the art.

[0104]Colorants also may be included in the nutritional supplement
compositions of the present invention. As used herein, the term
"colorant" includes compounds used to impart color to pharmaceutical
preparations. Such compounds include, by way of example and without
limitation, FD&C Red No. 3, FD&C Red No. 20, FD&C Yellow No. 6, FD&C Blue
No. 2, D&C Green No. 5, FD&C Orange No. 5, D&C Red No. 8, caramel, and
ferric oxide, red and others known to those of ordinary skill in the art.
Coloring agents also can include pigments, dyes, tints, titanium dioxide,
natural coloring agents, such as grape skin extract, beet red powder,
beta carotene, annato, carmine, turmeric, paprika and others known to
those of ordinary skill in the art. It is recognized that no colorant is
required in the nutritional supplement compositions described herein.

[0105]If desired, the compositions of the present invention may be sugar
coated or enteric coated by standard techniques. The unit dose forms may
be individually wrapped, packaged as multiple units on paper strips or in
vials of any size, without limitation. The swallowable, chewable or
dissolvable compositions of the present invention may be packaged in unit
dose, rolls, bulk bottles, blister packs and combinations thereof,
without limitation.

[0106]The swallowable, chewable or dissolvable compositions of the present
invention may be prepared using conventional methods and materials known
in the pharmaceutical art. For example, U.S. Pat. Nos. 5,215,754 and
4,374,082 relate to methods for preparing swallowable compositions. U.S.
Pat. No. 6,495,177 relates to methods to prepare chewable nutritional
supplements with improved mouthfeel. U.S. Pat. No. 5,965,162, relates to
compositions and methods for preparing multi-vitamin comestible units
which disintegrate quickly in the mouth, especially when chewed. Further,
all pharmaceutical carriers and formulations described herein are well
known to those of ordinary skill in the art, and determination of
workable proportions in any particular instance will generally be within
the capability of the person skilled in the art. Details concerning any
of the excipients of the invention may be found in WADE & WALLER,
HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (2nd ed. 1994). All active
ingredients, fillers and excipients are commercially available from
companies such as Aldrich Chemical Co., FMC Corp, Bayer, BASF, Alexi
Fres, Witco, Mallinckrodt, Rhodia, ISP, and others.

[0107]Other objectives, features and advantages of the present invention
will become apparent from the following specific examples. The specific
examples, while indicating specific embodiments of the invention, are
provided by way of illustration only. Accordingly, the present invention
also includes those various changes and modifications within the spirit
and scope of the invention that may become apparent to those skilled in
the art from this detailed description. The invention will be further
illustrated by the following non-limiting examples.

[0108]Without further elaboration, it is believed that one skilled in the
art, using the preceding description, can utilize the present invention
to the fullest extent. The following examples are illustrative only, and
not limiting of the remainder of the disclosure in any way whatsoever.

EXAMPLE 1

[0109]A composition of the following formulation was prepared in caplet
form, including the appropriate excipients, by standard methods known to
those of ordinary skill in the art:

[0110]A study is undertaken to evaluate the effectiveness of the
composition of the present invention in the treatment of patients. The
objective of the study is to determine whether oral intake of the
composition results in an improvement of the nutritional status of the
patient, either therapeutically or prophylacticly. A double-blind,
placebo controlled study is conducted over a twelve-month period. A total
of sixty subjects (30 men and 30 women), aged 40 to 85 years, suffering
from dietary restrictions or a disease state such as anorexia,
malnutrition, gastrointestinal disorders, chronic alcoholism, chronic
infections, acute infections, congestive heart failure, hyperthyroidism,
poorly controlled diabetes, cheilosis, gingivitis, sensitivity to iron,
hemosiderosis, hemochromatosis, or stomatitis, or a propensity or
disposition to such a disease state are chosen for the study. An initial
assessment of nutritional status is conducted utilizing methods such as
testing serum levels of 25-hydroxyvitamin D using a competitive binding
assay to assess vitamin D deficiency, the peroxide hemolysis test to
assess vitamin E deficiency, measurement of erythrocyte transketolase
activity to determine thiamine levels, determination of erytirocyte
glutathione reductase activity to assess riboflavin status, and high
performance liquid chromatography to directly measure PLP and pyridoxine
levels.

[0111]The sixty subjects are separated into two separate groups of fifteen
men and fifteen women. In the first group, each subject is administered 1
to 2 caplets, daily, of the composition as described in Example 1. In the
second group (control), each subject is administered 1 to 2 placebo
caplets, daily

[0112]An assessment of nutritional status for each subject is measured at
one-month intervals for a twelve month period as described above.
Specifically, in regard to vitamin D deficiency, the serum levels of
25-hydroxyvitamin D are measured to assess if they meet levels as high as
30 ng/ml or are increasing towards a level of 30 ng/ml. The data is
evaluated using multiple linear regression analysis and a standard
students t-test. In each analysis the baseline value of the outcome
variable is included in the model as a covariant. Treatment by covariant
interaction effects is tested by the method outlined by Weigel & Narvaez,
12 CONTROLLED CLINICAL TRIALS 378-94 (1991). If there are no significant
interaction effects, the interaction terms are removed from the model.
The regression model assumptions of normality and homogeneity of variance
of residuals are evaluated by inspection of the plots of residuals versus
predicted values. Detection of the temporal onset of effects is done
sequentially by testing for the presence of significant treatment effects
at 16, 12, and 8 weeks, proceeding to the earlier time in sequence only
when significant effects have been identified at each later time period.
Changes from the baseline within each group are evaluated using paired
t-tests. In addition, analysis of variance is performed on all baseline
measurements and measurable subject characteristics to assess homogeneity
between groups. All statistical procedures are conducted using the
Statistical Analysis System (SAS Institute Inc., Cary, N.C.). An alpha
level of 0.05 is used in all statistical tests.

[0113]A statistically significant improvement in the nutritional status is
preferably observed in the treated subjects upon completion of the study
over the controls. Specifically, in regard to vitamin D deficiency, the
tested serum levels of 25-hydroxyvitamin D are preferably in the range of
30 ng/ml for treated subjects. The study may also look at the progression
of the disease state, or the prevention or delay of a disease or disease
state, or the reduction of the severity of a disease. The differences
between nutritional state or the progression of the disease state, or the
prevention or delay of a disease or disease state, or the reduction of
the severity of a disease, between the treated subjects and controls are
preferably statistically significant and or observable by clinical or
other tests or evaluations. Therefore, the study confirms that oral
administration of the composition of the present invention is effective
as a nutritional supplement, either therapeutically or prophylacticly,
for example, in preventing the severity or delaying or preventing the
onset of a disease.

[0114]While there has been described what is presently believed to be the
preferred embodiments of the present invention, other and further
modifications and changes may be made without departing from the spirit
of the invention. All farther and other modifications and changes are
included that come within the scope of the invention as set forth in the
claims. The disclosure of all publications cited above are expressly
incorporated by reference in their entireties to the same extent as if
each were incorporated by reference individually.